MAUDE Adverse Event Report: DATASCOPE CORP. CS300 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3023-45
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Another initial reporter: (b)(6).Another contact info: (b)(6).Due to character limitation in e1, full event site name: (b)(6).A getinge field service engineer (fse) replaced expired safety disk to fix the error.The equipment passed all factory-specified performance and safety tests.The equipment has been delivered to the customer and is ready for clinical use.
Event or Problem Description
It was reported by customer that during routine maintenance, the cs300 intra aortic balloon pump had a leak in iab circuit alarm due to a leaking safety disc.There was no patient involved.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE CORP.; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: ewelina chorlowska ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 24528553
• Report Number: 2249723-2026-0001578
• Device Sequence Number: 12892407
• Product Code: DSP
• UDI-Device Identifier: 10607567108575
• UDI-Public: (01)10607567108575
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0998-00-3023-45
• Device Catalogue Number: 0998-00-3023-45
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2026
• Initial Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown